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The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 2 | Pages 229 - 233
1 Feb 2009
Kempshall PJ Metcalfe A Forster MC

As part of the government’s initiative to reduce waiting times for major joint surgery in Wales, the Cardiff and Vale NHS Trust sent 224 patients (258 knees) to the NHS Treatment Centre in Weston-Super-Mare for total knee replacement. The Kinemax total knee replacement system was used in all cases. The cumulative survival rate at three years was 79.2% (95% confidence interval (CI) 69.2 to 86.8) using re-operation for any cause as an endpoint and 85.3% (95% CI 75.9 to 91.8) using aseptic revision as an endpoint. This is significantly worse than that recorded in the published literature. These poor results have resulted in a significant impact on our service


The Bone & Joint Journal
Vol. 95-B, Issue 1 | Pages 122 - 126
1 Jan 2013
McWilliams AB Douglas SL Redmond AC Grainger AJ O’Connor PJ Stewart TD Stone MH

The results of hip and knee replacement surgery are generally regarded as positive for patients. Nonetheless, they are both major operations and have recognised complications. We present a review of relevant claims made to the National Health Service Litigation Authority. Between 1995 and 2010 there were 1004 claims to a value of £41.5 million following hip replacement surgery and 523 claims to a value of £21 million for knee replacement. The most common complaint after hip surgery was related to residual neurological deficit, whereas after knee replacement it was related to infection. Vascular complications resulted in the highest costs per case in each group.

Although there has been a large increase in the number of operations performed, there has not been a corresponding relative increase in litigation. The reasons for litigation have remained largely unchanged over time after hip replacement. In the case of knee replacement, although there has been a reduction in claims for infection, there has been an increase in claims for technical errors. There has also been a rise in claims for non-specified dissatisfaction. This information is of value to surgeons and can be used to minimise the potential mismatch between patient expectation, informed consent and outcome.

Cite this article: Bone Joint J 2013;95-B:122–6.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 834 - 841
1 Aug 2024
French JMR Deere K Jones T Pegg DJ Reed MR Whitehouse MR Sayers A

Aims. The COVID-19 pandemic has disrupted the provision of arthroplasty services in England, Wales, and Northern Ireland. This study aimed to quantify the backlog, analyze national trends, and predict time to recovery. Methods. We performed an analysis of the mandatory prospective national registry of all independent and publicly funded hip, knee, shoulder, elbow, and ankle replacements in England, Wales, and Northern Ireland between January 2019 and December 2022 inclusive, totalling 729,642 operations. The deficit was calculated per year compared to a continuation of 2019 volume. Total deficit of cases between 2020 to 2022 was expressed as a percentage of 2019 volume. Sub-analyses were performed based on procedure type, country, and unit sector. Results. Between January 2020 and December 2022, there was a deficit of 158,994 joint replacements. This is equivalent to over two-thirds of a year of normal expected operating activity (71.6%). There were 104,724 (-47.1%) fewer performed in 2020, 41,928 (-18.9%) fewer performed in 2021, and 12,342 (-5.6%) fewer performed in 2022, respectively, than in 2019. Independent-sector procedures increased to make it the predominant arthroplasty provider (53% in 2022). NHS activity was 73.2% of 2019 levels, while independent activity increased to 126.8%. Wales (-136.3%) and Northern Ireland (-121.3%) recorded deficits of more than a year’s worth of procedures, substantially more than England (-66.7%). It would take until 2031 to eliminate this deficit with an immediate expansion of capacity over 2019 levels by 10%. Conclusion. The arthroplasty deficit following the COVID-19 pandemic is now equivalent to over two-thirds of a year of normal operating activity, and continues to increase. Patients awaiting different types of arthroplasty, in each country, have been affected disproportionately. A rapid and significant expansion in services is required to address the deficit, and will still take many years to rectify. Cite this article: Bone Joint J 2024;106-B(8):834–841


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 783 - 794
1 Jul 2023
Karayiannis PN Warnock M Cassidy R Jones K Scott CEH Beverland D

Aims. The aim of this study was to report health-related quality of life (HRQoL) and joint-specific function in patients waiting for total hip or knee arthroplasty surgery (THA or TKA) in Northern Ireland, compared to published literature and a matched normal population. Secondary aims were to report emergency department (ED) and out-of-hours general practitioner (OOH GP) visits, new prescriptions of strong opioids, and new prescriptions of antidepressants while waiting. Methods. This was a cohort study of 991 patients on the waiting list for arthroplasty in a single Northern Ireland NHS trust: 497 on the waiting list for ≤ three months; and 494 waiting ≥ three years. Postal surveys included the EuroQol five-dimension five-level questionnaire (EQ-5D-5L), visual analogue scores (EQ-VAS), and Oxford Hip and Knee scores to assess HRQoL and joint-specific function. Electronic records determined prescriptions since addition to the waiting list and patient attendances at OOH GP/EDs. Results. Overall, 712/991 (71.8%) responded at ≤ three months for THA (n = 164) and TKA (n = 199), and ≥ three years for THA (n = 88) and TKA (n = 261). The median EQ-5D-5L score in those waiting ≤ three months was 0.155 (interquartile range (IQR) -0.118 to 0.375) and 0.189 (IQR -0.130 to 0.377) for ≥ three years. Matched controls had a median EQ-5D-5L 0.837 (IQR 0.728 to 1.000). Compared to matched controls, EQ-5D-5L scores were significantly lower in both waiting cohorts (p < 0.001) with significant differences found in every domain. Negative scores, indicating a state “worse than death”, were present in 40% at ≤ three months and 38% at ≥ three years. Patients waiting ≥ three years had significantly more opioid (28.4% vs 15.2%; p < 0.001) and antidepressant prescriptions (15.2% vs 9.9%; p = 0.034) and significantly more joint-related attendances at unscheduled care (11.7% vs 0% with ≥ one ED attendance (p < 0.001) and (25.5% vs 2.5% ≥ one OOH GP attendance (p < 0.001)). Conclusion. Patients on waiting lists in Northern Ireland are severely disabled with the worst HRQoL and functional scores studied. The lack of deterioration in EQ-5D-5L and joint-specific scores between patients waiting ≤ three months and ≥ three years likely reflects floor effects of these scores. Prolonged waits were associated with increased dependence on strong opiates, depression, and attendances at unscheduled care. Cite this article: Bone Joint J 2023;105-B(7):783–794


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 687 - 695
1 Jun 2022
Sabah SA Knight R Alvand A Beard DJ Price AJ

Aims. Routinely collected patient-reported outcome measures (PROMs) have been useful to quantify and quality-assess provision of total hip arthroplasty (THA) and total knee arthroplasty (TKA) in the UK for the past decade. This study aimed to explore whether the outcome following primary THA and TKA had improved over the past seven years. Methods. Secondary data analysis of 277,430 primary THAs and 308,007 primary TKAs from the NHS PROMs programme was undertaken. Outcome measures were: postoperative Oxford Hip/Knee Score (OHS/OKS); proportion of patients achieving a clinically important improvement in joint function (responders); quality of life; patient satisfaction; perceived success; and complication rates. Outcome measures were compared based on year of surgery using multiple linear and logistic regression models. Results. For primary THA, multiple linear regression modelling found that more recent year of surgery was associated with higher postoperative OHS (unstandardized coefficient (B) 0.15 points (95% confidence interval (CI) 0.14 to 0.17); p < 0.001) and higher EuroQol five-dimension index (EQ-5D) utility (B 0.002 (95% CI 0.001 to 0.002); p < 0.001). The odds of being a responder (odds ratio (OR) 1.02 (95% CI 1.02 to 1.03); p < 0.001) and patient satisfaction (OR 1.02 (95% CI 1.01 to 1.03); p < 0.001) increased with year of surgery, while the odds of any complication reduced (OR 0.97 (95% CI 0.97 to 0.98); p < 0.001). No trend was found for perceived success (p = 0.555). For primary TKA, multiple linear regression modelling found that more recent year of surgery was associated with higher postoperative OKS (B 0.21 points (95% CI 0.19 to 0.22); p < 0.001) and higher EQ-5D utility (B 0.002 (95% CI 0.002 to 0.003); p < 0.001). The odds of being a responder (OR 1.04 (95% CI 1.03 to 1.04); p < 0.001), perceived success (OR 1.02 (95% CI 1.01 to 1.02); p < 0.001), and patient satisfaction (OR 1.02 (95% CI 1.01 to 1.02); p < 0.001) all increased with year of surgery, while the odds of any complication reduced (OR 0.97 (95% CI 0.97 to 0.97); p < 0.001). Conclusion. Nearly all patient-reported outcomes following primary THA/TKA improved by a small amount over the past seven years. Due to the high proportion of patients achieving good outcomes, PROMs following THA and TKA may need to focus on better discrimination of patients achieving high scores to be able to continue to measure improvement in outcomes. Cite this article: Bone Joint J 2022;104-B(6):687–695


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 950 - 958
1 Jul 2020
Dakin H Eibich P Beard D Gray A Price A

Aims. To assess how the cost-effectiveness of total hip arthroplasty (THA) and total knee arthroplasty (TKA) varies with age, sex, and preoperative Oxford Hip or Knee Score (OHS/OKS); and to identify the patient groups for whom THA/TKA is cost-effective. Methods. We conducted a cost-effectiveness analysis using a Markov model from a United Kingdom NHS perspective, informed by published analyses of patient-level data. We assessed the cost-effectiveness of THA and TKA in adults with hip or knee osteoarthritis compared with having no arthroplasty surgery during the ten-year time horizon. Results. THA and TKA cost < £7,000 per quality-adjusted life-year (QALY) gained at all preoperative scores below the absolute referral thresholds calculated previously (40 for OHS and 41 for OKS). Furthermore, THA cost < £20,000/QALY for patients with OHS of ≤ 45, while TKA was cost-effective for patients with OKS of ≤ 43, since the small improvements in quality of life outweighed the cost of surgery and any subsequent revisions. Probabilistic and one-way sensitivity analyses demonstrated that there is little uncertainty around the conclusions. Conclusion. If society is willing to pay £20,000 per QALY gained, THA and TKA are cost-effective for nearly all patients who currently undergo surgery, including all patients at and above our calculated absolute referral thresholds. Cite this article: Bone Joint J 2020;102-B(7):950–958


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 641 - 648
1 Jun 2023
Bloch BV Matar HE Berber R Gray WK Briggs TWR James PJ Manktelow ARJ

Aims

Revision total knee arthroplasty (rTKA) and revision total hip arthroplasty (rTHA) are complex procedures with higher rates of re-revision, complications, and mortality compared to primary TKA and THA. We report the effects of the establishment of a revision arthroplasty network (the East Midlands Specialist Orthopaedic Network; EMSON) on outcomes of rTKA and rTHA.

Methods

The revision arthroplasty network was established in January 2015 and covered five hospitals in the Nottinghamshire and Lincolnshire areas of the East Midlands of England. This comprises a collaborative weekly multidisciplinary meeting where upcoming rTKA and rTHA procedures are discussed, and a plan agreed. Using the Hospital Episode Statistics database, revision procedures carried out between April 2011 and March 2018 (allowing two-year follow-up) from the five network hospitals were compared to all other hospitals in England. Age, sex, and mean Hospital Frailty Risk scores were used as covariates. The primary outcome was re-revision surgery within one year of the index revision. Secondary outcomes were re-revision surgery within two years, any complication within one and two years, and median length of hospital stay.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 166 - 173
1 Feb 2024
Scott CEH Yapp LZ MacDonald DJ Howie CR Clement ND

Aims

The primary aim was to assess change in health-related quality of life (HRQoL) of patients as they waited from six to 12 months for a total hip (THA) or total or partial knee arthroplasty (KA). Secondary aims were to assess change in joint-specific function, mental health, quality of sleep, number living in a state worse than death (WTD), wellbeing, and patient satisfaction with their healthcare.

Methods

This prospective study included 142 patients awaiting a THA (mean age 66.7 years (SD 11.4); 71 female) and 214 patients awaiting KA (mean age 69.7 years (SD 8.7); 117 female). Patients completed questionnaires (EuroQol five-dimension health questionnaire (EQ-5D), Oxford Hip and Knee Scores (OHS/OKS), Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Score (HADS), University of California, Los Angeles Activity Scale, wellbeing assessment, and satisfaction with their healthcare) at six and 12 months while awaiting surgery.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 688 - 695
1 Jul 2024
Farrow L Zhong M Anderson L

Aims

To examine whether natural language processing (NLP) using a clinically based large language model (LLM) could be used to predict patient selection for total hip or total knee arthroplasty (THA/TKA) from routinely available free-text radiology reports.

Methods

Data pre-processing and analyses were conducted according to the Artificial intelligence to Revolutionize the patient Care pathway in Hip and knEe aRthroplastY (ARCHERY) project protocol. This included use of de-identified Scottish regional clinical data of patients referred for consideration of THA/TKA, held in a secure data environment designed for artificial intelligence (AI) inference. Only preoperative radiology reports were included. NLP algorithms were based on the freely available GatorTron model, a LLM trained on over 82 billion words of de-identified clinical text. Two inference tasks were performed: assessment after model-fine tuning (50 Epochs and three cycles of k-fold cross validation), and external validation.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1215 - 1224
1 Nov 2022
Clement ND Wickramasinghe NR Bayram JM Hughes K Oag E Heinz N Fraser E Jefferies JG Dall GF Ballantyne A Jenkins PJ

Aims

The primary aim of this study was to assess whether patients waiting six months or more for a total hip (THA) or knee (KA) arthroplasty had a deterioration in their health-related quality of life (HRQoL). Secondary aims were to assess changes in frailty and the number of patients living in a state considered to be worse than death (WTD), and factors associated with changes in HRQoL and frailty.

Methods

This cross-sectional study included 326 patients, 150 males (46.0%) and 176 females (54.0%), with a mean age of 68.6 years (SD 9.8) who were randomly selected from waiting lists at four centres and had been waiting for six months or more (median 13 months, interquartile range 10 to 21) for a primary THA (n = 161) or KA (n = 165). The EuroQol five-dimension questionnaire (EQ-5D) and visual analogue scores (EQ-VAS), Rockwood Clinical Frailty Scale (CFS), and 36-Item Short Form Survey subjective change in HRQoL were assessed at the time and recalled for six months earlier. A state that was WTD was defined as an EQ-5D of less than zero.


Aims

The aim of this study was to evaluate the healthcare costs and benefits of enoxaparin compared to aspirin in the prevention of symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) using data from the CRISTAL trial.

Methods

This trial-based economic analysis reports value for money as incremental cost per quality-adjusted life-year (QALY) gained in 2022 Australian dollars, compared to a single threshold value of AUD$70,000 per QALY. Event costs were estimated based on occurrence of VTEs and bleeds, and on published guidelines for treatment. Unit costs were taken from Australian sources. QALYs were estimated using CRISTAL six-month follow-up data. Sensitivity analyses are presented that vary the cost of VTE treatment, and extend the analyses to two years.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1052 - 1059
1 Sep 2022
Penfold CM Judge A Sayers A Whitehouse MR Wilkinson JM Blom AW

Aims

Our main aim was to describe the trend in the comorbidities of patients undergoing elective total hip arthroplasties (THAs) and knee arthroplasties (KAs) between 1 January 2005 and 31 December 2018 in England.

Methods

We combined data from the National Joint Registry (NJR) on primary elective hip and knee arthroplasties performed between 2005 and 2018 with pre-existing conditions recorded at the time of their primary operation from Hospital Episodes Statistics. We described the temporal trend in the number of comorbidities identified using the Charlson Comorbidity Index, and how this varied by age, sex, American Society of Anesthesiologists (ASA) grade, index of multiple deprivation, and type of KA.


The Bone & Joint Journal
Vol. 98-B, Issue 2 | Pages 201 - 208
1 Feb 2016
Kingsbury SR Dube B Thomas CM Conaghan PG Stone MH

Aims. Increasing demand for total hip and knee arthroplasty (THA/TKA) and associated follow-up has placed huge demands on orthopaedic services. Feasible follow-up mechanisms are therefore essential. . Methods. We conducted an audit of clinical follow-up decision-making for THA/TKA based on questionnaire/radiograph review compared with local practice of Arthroplasty Care Practitioner (ACP)-led outpatient follow-up. In all 599 patients attending an ACP-led THA/TKA follow-up clinic had a pelvic/knee radiograph, completed a pain/function questionnaire and were reviewed by an ACP. An experienced orthopaedic surgeon reviewed the same radiographs and questionnaires, without patient contact or knowledge of the ACP’s decision. Each pathway classified patients into: urgent review, annual monitoring, routine follow-up or discharge. . Results. In total, 401 hip and 198 knee patients were included. There was substantial agreement between the ACP and surgeon for both hip (kappa = 0.69, 95% confidence interval (CI) 0.62 to 0.76) and knee (kappa = 0.81, 95% CI 0.74 to 0.88). Positive agreement was very high for discharge and routine follow-up; however the ACP was more likely to select annual monitoring and the surgeon urgent review. . Discussion. Review of the questionnaire/radiograph together identified all patients in need of increased surveillance, with good agreement for on-going patient management. However, review of the radiograph or questionnaire alone missed some patients with potential problems. A radiograph in conjunction with a questionnaire as a review may represent a cost effective THA/TKA follow-up mechanism. Take home message: A questionnaire and radiograph-based remote review may represent a cost-effective total joint arthroplasty follow-up mechanism; thereby reducing the considerable burden that follow-up currently places on the NHS. Cite this article: Bone Joint J 2016;98-B:201–8


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 123 - 129
1 Jan 2010
Jameson SS Bottle A Malviya A Muller SD Reed MR

The National Institute for Clinical Excellence (NICE) produces recommendations on appropriate treatment within the National Health Service (NHS) in England and Wales. The NICE guidelines on prophylaxis for venous thromboembolism in orthopaedic surgery recommend that all patients be offered a low molecular weight heparin (LMWH). The linked hospital episode statistics of 219 602 patients were examined to determine the rates of complications following lower limb arthroplasty for the 12-month periods prior to and following the publication of these guidelines. These were compared with data from the National Joint Registry (England and Wales) regarding the use of LMWH during the same periods. There was a significant increase in the reported use of LMWH (59.5% to 67.6%, p < 0.001) following the publication of the guidelines. However, the 90-day venous thromboembolism events actually increased slightly following total hip replacement (THR, 1.69% to 1.84%, p = 0.06) and remained unchanged following total knee replacement (TKR, 1.99% to 2.04%). Return to theatre in the first 30 days for infection did not show significant changes. There was an increase in the number of patients diagnosed with thrombocytopenia, which was significant following THR (0.11% to 0.16%, p = 0.04). The recommendations from NICE are based on predicted reductions in venous thromboembolism events, reducing morbidity, mortality and costs to the NHS. The early results in orthopaedic patients do not support these predictions, but do show an increase in complications


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 672 - 680
1 Apr 2021
Clement ND Scott CEH Murray JRD Howie CR Deehan DJ

Aims

The aim of this study was to assess the quality of life of patients on the waiting list for a total hip (THA) or knee arthroplasty (KA) during the COVID-19 pandemic. Secondary aims were to assess whether length of time on the waiting list influenced quality of life and rate of deferral of surgery.

Methods

During the study period (August and September 2020) 843 patients (THA n = 394, KA n = 449) from ten centres in the UK reported their EuroQol five dimension (EQ-5D) scores and completed a waiting list questionnaire (2020 group). Patient demographic details, procedure, and date when listed were recorded. Patients scoring less than zero for their EQ-5D score were defined to be in a health state “worse than death” (WTD). Data from a retrospective cohort (January 2014 to September 2017) were used as the control group.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 681 - 688
1 Apr 2021
Clement ND Hall AJ Kader N Ollivere B Oussedik S Kader DF Deehan DJ Duckworth AD

Aims

The primary aim was to assess the rate of postoperative COVID-19 following hip and knee arthroplasty performed in March 2020 in the UK. The secondary aims were to assess whether there were clinical factors associated with COVID-19 status, the mortality rate of patients with COVID-19, and the rate of potential COVID-19 in patients not presenting to healthcare services.

Methods

A multicentre retrospective study was conducted of patients undergoing hip or knee arthroplasty during the first wave of the COVID-19 pandemic (1 March 2020 to 31 March 2020) with a minimum of 60 days follow-up. Patient demographics, American Society of Anesthesiologists grade, procedure type, primary or revision, length of stay (LOS), COVID-19 test status, and postoperative mortality were recorded. A subgroup of patients (n = 211) who had not presented to healthcare services after discharge were contacted and questioned as to whether they had symptoms of COVID-19.


The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 56 - 64
1 Jan 2021
Podmore B Hutchings A Skinner JA MacGregor AJ van der Meulen J

Aims

Access to joint replacement is being restricted for patients with comorbidities in a number of high-income countries. However, there is little evidence on the impact of comorbidities on outcomes. The purpose of this study was to determine the safety and effectiveness of hip and knee arthroplasty in patients with and without comorbidities.

Methods

In total, 312,079 hip arthroplasty and 328,753 knee arthroplasty patients were included. A total of 11 common comorbidities were identified in administrative hospital records. Safety risks were measured by assessing length of hospital stay (LOS) and 30-day emergency readmissions and mortality. Effectiveness outcomes were changes in Oxford Hip or Knee Scores (OHS/OKS) (scale from 0 (worst) to 48 (best)) and in health-related quality of life (EQ-5D) (scale from 0 (death) to 1 (full health)) from immediately before, to six months after, surgery. Regression analysis was used to estimate adjusted mean differences (LOS, change in OHS/OKS/EQ-5D) and risk differences (readmissions and mortality).


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 941 - 949
1 Jul 2020
Price AJ Kang S Cook JA Dakin H Blom A Arden N Fitzpatrick R Beard DJ

Aims

To calculate how the likelihood of obtaining measurable benefit from hip or knee arthroplasty varies with preoperative patient-reported scores.

Methods

Existing UK data from 222,933 knee and 209,760 hip arthroplasty patients were used to model an individual’s probability of gaining meaningful improvement after surgery based on their preoperative Oxford Knee or Hip Score (OKS/OHS). A clinically meaningful improvement after arthroplasty was defined as ≥ 8 point improvement in OHS, and ≥ 7 in OKS.


The Bone & Joint Journal
Vol. 101-B, Issue 8 | Pages 960 - 969
1 Aug 2019
Odgaard A Laursen MB Gromov K Troelsen A Kristensen PW Schrøder H Madsen F Overgaard S

Aims

The aim of this study was to give estimates of the incidence of component incompatibility in hip and knee arthroplasty and to test the effect of an online, real-time compatibility check.

Materials and Methods

Intraoperative barcode registration of arthroplasty implants was introduced in Denmark in 2013. We developed a compatibility database and, from May 2017, real-time compatibility checking was implemented and became part of the registration. We defined four classes of component incompatibility: A-I, A-II, B-I, and B-II, depending on an assessment of the level of risk to the patient (A/B), and on whether incompatibility was knowingly accepted (I/II).


The Bone & Joint Journal
Vol. 99-B, Issue 12 | Pages 1618 - 1628
1 Dec 2017
Hunt LP Blom A Wilkinson JM

Aims

To investigate whether elective joint arthroplasty performed at the weekend is associated with a different 30-day mortality versus that performed between Monday and Friday.

Patients and Methods

We examined the 30-day cumulative mortality rate (Kaplan-Meier) for all elective hip and knee arthroplasties performed in England and Wales between 1st April 2003 and 31st December 2014, comprising 118 096 episodes undertaken at the weekend and 1 233 882 episodes performed on a weekday. We used Cox proportional-hazards regression models to assess for time-dependent variation and adjusted for identified risk factors for mortality.